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Clinical Trials/ISRCTN47701105
ISRCTN47701105CompletedNot Applicable

TRI-stent Adjudication Study - Low risk of Restenosis

Academic Medical Centre (AMC) (Netherlands)0 sites1,260 target enrollmentStarted: August 23, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,260
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •Clinically stable patients undergoing a Percutaneous Coronary Intervention (PCI) for a coronary artery lesion with a low risk of restenosis are candidates for entry into this study.
  • •A target lesion is considered to be at a low risk of restenosis if all of the following apply:
  • •1. A de novo lesion located in a native epicardial vessel with a Reference Vessel Diameter (RVD) greater than 2.8 mm by visual estimation
  • •2. A de novo lesion with a length of smaller than 20 mm by visual estimation
  • •3. A de novo lesion with a Thrombolysis in Myocardial Infarction (TIMI) flow equal to or greater than 1
  • •4. The patient does not have diabetes mellitus

Exclusion Criteria

  • •1. Younger than 18 years of age
  • •2. A target lesion located in the left main coronary artery
  • •3. A Chronic Totally Occluded (CTO) target lesion
  • •4. A target lesion with involvement of a side branch, which is equal to or greater than 2.0 mm in diameter by visual estimation
  • •5. A restenotic target lesion
  • •6. A target lesion in an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  • •7. A target lesion(s) with an indication for treatment with a Drug-Eluting Stent (DES)
  • •8. Urgent need for revascularisation
  • •9. ST Elevation Myocardial Infarction (STEMI) within the past six weeks
  • •10. Ventricular tachyarrhythmias within the past week
  • •11. A diabetic patient
  • •12. Known renal insufficiency (e.g. serum creatinine level of more than 200 µgram/L)
  • •13. Platelet count of less than 100,000 cells/mm^3 or more than 700,000 cells/mm^3, a White Blood Cell (WBC) count of less than 3,000 cells/mm^3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • •14. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomisation
  • •15. History of a hemorrhagic stroke at any time, or stroke or Transient Ischaemic Accident (TIA) of any aetiology within 30 days of randomisation
  • •16. Previous or scheduled chemotherapy or radiotherapy within 30 days prior or after the procedure
  • •17. On immune-suppression therapy or with known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  • •18. Severe hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure over 100 mmHg, after treatment)
  • •19. Contraindication for treatment with the Genous™ EPC capturing stent, such as previous administration of murine therapeutic antibodies and exhibition of sensitisation through the production of Human Anti-Murine Antibodies (HAMA)
  • •20. Known hypersensitivity or contraindication to aspirin, heparin or clopidogrel
  • •21. Elective surgery, planned within the first six months after the procedure that requires discontinuing either aspirin or clopidogrel
  • •22. Previous heart transplant or any other organ transplant
  • •23. Previous participation in this study
  • •24. Circumstances that prevent follow-up (no permanent home or address, transient, etc.)
  • •25. Women who are pregnant or who are of childbearing potential who do not use adequate contraception

Investigators

Sponsor
Academic Medical Centre (AMC) (Netherlands)

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